Treating Nectin-4-positive Advanced Breast Cancer with XKDCT293 (Nectin-4-CAR-T)

NCT06724835 | Recruiting Phase 1

• 1 other identifier: 2023YP31H01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center, single-arm, dose-escalation exploratory clinical trial of the safety, efficacy, and pharmacokinetics of XKDCT 293 (Nectin-4-CAR-T) in Nectin-4-positive advanced breast cancer

Conditions

Advanced Breast Cancer

Keywords

Nectin-4 positive advanced breast cancer

Outcome Measures

Primary Outcomes (3)

• Dose limiting toxicity (DLT)

  Dose limiting toxicity (DLT) in the dose escalation phase

  28 days of single infusion

• Incidence of Treatment Related adverse events (AEs)

  Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs)

  1 year

• Maximum tolerated dose (MTD)

  Maximum tolerated dose (MTD) in the dose escalation phase

  28 days of single infusion

Secondary Outcomes (2)

• Cellular metabolic kinetics indicators

  1 year

• objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS)

  1 year

Study Arms (1)

Autologous targeted Nectin4 chimeric antigen receptor T cell injection

EXPERIMENTAL

Autologous targeted Nectin4 chimeric antigen receptor T cell injection

Drug: XKDCT293; Other: CAR-T cell

Interventions

XKDCT293 DRUG

Autologous targeted Nectin4 chimeric antigen receptor T cell injection

Autologous targeted Nectin4 chimeric antigen receptor T cell injection

CAR-T cell OTHER

Nectin-4-CAR-T

Autologous targeted Nectin4 chimeric antigen receptor T cell injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ·You must meet all of the following conditions to be eligible for the group：
• Understand and voluntarily sign the informed consent form;
• Age at screening ranged from 18 to 75 years (including the cutoff value), regardless of gender;
• Locally advanced or metastatic breast cancer that is unresectable as confirmed by histology or cytology, including triple-negative breast cancer, Her-2-positive, and HR-positive breast cancer;
• Histological or cytological tumor specimens were confirmed by immunohistochemistry to have moderate to high expression of nectin-4 (expression intensity ≥2+ and tumor cell positive rate ≥50%);
• Patients who have received standard systemic treatment for breast cancer recommended by the Breast Cancer Diagnosis and Treatment Guidelines (2022 Edition) and have had imaging or other objective evidence of disease progression after receiving standard treatment; or patients with refractory breast cancer who cannot tolerate standard treatment or have contraindications to standard treatment, and who have at least one measurable lesion (according to RECIST version 1.1, the long diameter of the measurable lesion on spiral CT scan is ≥10mm or the short diameter of the enlarged lymph node is ≥15mm, see Appendix 1 for RECIST version 1.1); Note: Treatment failure is defined as disease progression during treatment or recurrence after treatment.
• Definition of intolerance : the occurrence of grade ≥ IV hematological toxicity, grade ≥ III non-hematological toxicity, or grade ≥ III damage to major organs such as heart, liver, and kidney during treatment (refer to NCI-CTCAE v5.0 standards), or a comprehensive assessment by the investigator.
• The expected survival time at enrollment was greater than 12 weeks;
• During screening, laboratory tests must meet the following requirements:
• White blood cell count ≥3.0×10\^9 /L;
• Neutrophil count ≥1.5×10\^9 /L;
• Lymphocyte count ≥ 0.5 × 10\^9 /L;
• Hemoglobin ≥90 g/L;
• Platelet count ≥75×10\^9 /L;
• Serum total bilirubin ≤2.0× upper limit of normal (ULN);

You may not qualify if:

• ·Anyone who has any of the following conditions cannot be selected as a subject：
• Pregnant or breastfeeding women;
• Those who have a history of allergy to any component of the cell product ;
• Suffering from other malignant tumors, except for the following: cured non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, superficial bladder cancer, and other malignant tumors with a disease-free survival period of more than 5 years;
• Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive, and HBV DNA copy number positive; Hepatitis C antibody (HCV-Ab) positive; Anti-Treponema pallidum antibody (TP-Ab) positive; Human immunodeficiency virus antibody (HIV-Ab) positive; Those who meet any of the following conditions;
• Previous anti-tumor treatment or clinical trial participation:
• Previously received CAR-T therapy or other gene-edited cell therapy;
• Participated in other clinical studies within 28 days before reinfusion;
• Received local radiotherapy within 7 days or at least 5 half-lives (whichever is longer) before apheresis or small molecule chemotherapy drugs;
• Daily use of systemic glucocorticoids ≥ 15 mg within 7 days before apheresis, excluding inhaled corticosteroids;
• Previously received Nectin-4 targeted therapy;
• Live vaccine or live attenuated vaccine received within 4 weeks before single collection;
• Surgery has been performed within 2 weeks before apheresis and the researchers believe that it may affect the patient's safety;
• The investigators judged that there were comorbidities that required the use of systemic corticosteroids or other immunosuppressive drugs during the study;
• Those who are known to have life-threatening hypersensitivity reactions or other intolerances to cyclophosphamide or fludarabine or severe allergic constitutions; those who have hypersensitivity constitutions, are allergic to human serum albumin, DMSO, etc.; those who are allergic to commonly used first aid and anesthetic drugs;

Sponsors & Collaborators

• Shenzhen Celconta Life Science Co., Ltd.: lead

Study Sites (1)

AnYang Tumor Hospital

Anyang, Henan, 455000, China

RECRUITING

MeSH Terms

Interventions

Immunotherapy, Adoptive

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Central Study Contacts

Baozhong Li

CONTACT

13937238883; libaozhong99@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Model Description

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 9, 2024
• Study Start: March 11, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)